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Local Anesthetic

HTX-011 for Pain relief

Phase 2
Waitlist Available
Research Sponsored by Heron Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 72 hours
Awards & highlights

Study Summary

This trial is testing if a new, investigational drug is safe and effective in children undergoing surgery to repair a groin hernia.

Eligible Conditions
  • Pain relief

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~72 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 72 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area under the concentration-time curve (AUC) from Time 0 extrapolated to infinity (AUCinf)
Maximum concentration (Cmax)
Time of occurrence of maximum concentration (Tmax)
Secondary outcome measures
AUC of the Numeric Rating Scale pain intensity scores at rest (NRS-R)
Adolescents ≥12 to <17 years of age (Cohort 1): area under the curve (AUC) of the Numeric Rating Scale of pain intensity scores with activity (NRS-A)
Children ≥3 to <6 years of age (Cohort 3): AUC of the Faces, Legs, Activity, Cry, Consolability (FLACC) scale pain intensity scores
+4 more

Side effects data

From 2018 Phase 3 trial • 418 Patients • NCT03237481
18%
Nausea
17%
Constipation
15%
Dizziness
13%
Headache
9%
Bradycardia
9%
Dysgeusia
8%
Skin odour abnormal
4%
Tremor
4%
Vomiting
2%
Tinnitus
1%
Incision site haematoma
1%
Chronic obstructive pulmonary disease
1%
Gamma-glutamyltransferase increase
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment Group 1: HTX-011
Treatment Group 2: Bupivacaine HCI
Treatment Group 3: Saline Placebo

Trial Design

10Treatment groups
Experimental Treatment
Active Control
Group I: Cohort 3: HTX-011Experimental Treatment2 Interventions
Children ≥3 to <6 years of age. Dose to be determined from Cohorts 1 and 2.
Group II: Cohort 2 Part B: HTX-011Experimental Treatment2 Interventions
Children ≥6 to <12 years of age. Dose to be determined from Cohort 1.
Group III: Cohort 2 Part A: HTX-011Experimental Treatment2 Interventions
Children ≥6 to <12 years of age. Dose to be determined from Cohort 1.
Group IV: Cohort 1 Part B: HTX-011Experimental Treatment2 Interventions
Adolescents ≥12 to <17 years of age. Dose to be determined from Cohort 1 Part A.
Group V: Cohort 1 Part A: HTX-011Experimental Treatment2 Interventions
Adolescents ≥12 to <17 years of age. A single dose of HTX-011 via instillation into the surgical site.
Group VI: Cohort 1 Part A: bupivacaine HClActive Control1 Intervention
Adolescents ≥12 to <17 years of age. A single dose of bupivacaine HCl 0.25% (without epinephrine) via injection into the surgical site.
Group VII: Cohort 2 Part B: bupivacaine HClActive Control1 Intervention
Children ≥6 to <12 years of age. A single dose of bupivacaine HCl 0.25% (without epinephrine) via injection into the surgical site
Group VIII: Cohort 1 Part B: bupivacaine HClActive Control1 Intervention
Adolescents ≥12 to <17 years of age. A single dose of bupivacaine HCl 0.25% (without epinephrine) via injection into the surgical site
Group IX: Cohort 2 Part A: bupivacaine HClActive Control1 Intervention
Children ≥6 to <12 years of age. A single dose of bupivacaine HCl 0.25% (without epinephrine) via injection into the surgical site
Group X: Cohort 3: bupivacaine HClActive Control1 Intervention
Children ≥3 to <6 years of age. A single dose of bupivacaine HCl 0.25% (without epinephrine) via injection into the surgical site
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Luer Lock Applicator
2019
Completed Phase 3
~180
HTX-011
2019
Completed Phase 4
~2390

Find a Location

Who is running the clinical trial?

Heron TherapeuticsLead Sponsor
27 Previous Clinical Trials
6,186 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I eligible to participate in this research?

"In order to be eligible for the trial, applicants must possess an analgesic status and fall within the specified age range of 3-16. The research is aiming to recruit 336 individuals in total."

Answered by AI

Has HTX-011 been studied through other clinical research projects?

"Presently, 18 Phase 3 trials are being conducted on HTX-011 with a total of 109 active clinical studies. The majority of these experiments take place in Philadelphia, Pennsylvania but there are research sites located around the world counting to 144 worldwide."

Answered by AI

Are there any age restrictions for enrolment in this experiment?

"The eligibility standards of this trial necessitate that all applicants are between 3 and 16 years old. For individuals younger than 18, there are 28 trials available; for those above 65, 187 studies can be found."

Answered by AI

Is the enrollment period still open for this clinical study?

"This trial is no longer seeking participants, having been first posted on September 1st 2022 and last updated on May 11th 2022. There are 123 studies looking for individuals with analgesia and 109 trials involving HTX-011 that require enrolment right now."

Answered by AI

To what extent has recruitment for this clinical trial been successful?

"Unfortunately, the recruitment period for this trial has ended. The clinical trial first appeared on September 1st 2022 and was last updated on May 11th 2022. If you are still looking to participate in a medical study, there presently exists 123 trials searching for participants with analgesia as well as 109 studies involving HTX-011 that are actively recruiting patients."

Answered by AI

What medical conditions does HTX-011 typically treat?

"HTX-011 can be leveraged to treat permphigus, acute nonspecific tenosynovitis, and general anesthesia."

Answered by AI

What safety measures have been taken to ensure HTX-011 use is without peril?

"Our team has rated HTX-011's safety a 2 due to the fact that Phase 2 trials only provide limited evidence regarding its efficacy and no data demonstrating its safety."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Pediatric Postoperative Analgesia Herniorrhaphy Study
2023. "Pediatric Postoperative Analgesia Herniorrhaphy Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03922048.
~0 spots leftby Nov 2025
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